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SHORT HILLS, N.J. — Bayshore Pharmaceuticals, a manufacturer and marketer of generic drugs, has received its first Abbreviated New Drug Application (ANDA) approval from the Food and Drug Administration for methscopolamine bromide tablets.
The company said Friday that its methscopolamine bromide product, which comes in dosages of 2.5 mg and 5 mg, is the generic equivalent of Fougera’s Pamine.
Methscopolamine bromide is indicated for the treatment of peptic ulcers.
"Needless to say, the first ANDA approval for any generic pharmaceutical company is a milestone event, and Bayshore is thrilled to have achieved this accomplishment. We are now focusing on preparing for its commercial launch and fulfilling the expectations and requirements of our customers," stated Mark Moshier, president of Bayshore, which was founded in 2011 and is based in Short Hills, N.J.
